A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Roche

Status and phase: Completed; Phase 1

Conditions: Geographic Atrophy

Treatments: Drug: RO7303359

Study type: Interventional

Funder types: Industry

Identifiers

NCT04615325

GR42163

Details and patient eligibility

About

This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.

Enrollment: 37 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Ocular Inclusion Criteria Study Eye:

• Visual acuity: BCVA letter score of 19-48 ETDRS letters (Snellen equivalent of 20/125-20/400) using ETDRS charts at a starting distance of 4 meters
• Well-demarcated area of GA secondary to AMD in the absence of choroidal neovascularization (CNV)
• GA area must be >/= 0.5 disc area (1.25 mm^2)

Ocular Exclusion Criteria, Study Eye:

• GA in the study eye due to causes other than AMD
• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
• Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
• Prior treatment with photodynamic therapy, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy

Ocular Exclusion Criteria, Both eyes:

• Evidence of prior or active CNV
• Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, irrespective of the route of administration (i.e. ocular or systemic) within the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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37 participants in 4 patient groups

Single Ascending Dose Stage

Experimental group

Description:

Participants will receive a single dose of RO7303359, in multiple escalating cohorts (A-D).

Treatment:

Drug: RO7303359

Expansion Cohort Stage

Experimental group

Description:

Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage.

Treatment:

Drug: RO7303359

Optional Cohort E

Experimental group

Description:

An optional additional cohort may be added with the dose not exceed the MTD or MTeD.

Treatment:

Drug: RO7303359

Optional cohort F

Experimental group

Description:

An optional additional cohort may be added with the dose not exceed the MTD or MTeD.

Treatment:

Drug: RO7303359